FDA 510(k) Application Details - K970684

Device Classification Name	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase   More FDA Info for this Device
510(K) Number	K970684
Device Name	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Applicant	RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN BT29 4QY IE Other 510(k) Applications for this Company
Contact	PONE ARMSTRONG Other 510(k) Applications for this Contact
Regulation Number	862.1440   More FDA Info for this Regulation Number
Classification Product Code	CFJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/24/1997
Decision Date	05/07/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review